Devices

Device Recall Pinnacle Destination Guiding Sheath, 7 French, 90 cm

Model / Serial
RSC02
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama
Product Description
Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 || Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
Manufacturer
Terumo Medical Corporation
1 Event
- Recall of Device Recall Pinnacle Destination Guiding Sheath, 7 French, 90 cm

Manufacturer

Terumo Medical Corporation

Manufacturer Address
Terumo Medical Corporation, 950 Elkton Blvd, Elkton MD 21921-5322
Manufacturer Parent Company (2017)
Terumo Corp.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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